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This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers
The subjects who are adequately eligible to attend this clinical trial via screening will be assigned to four cohorts (five if necessary) and administered a single dose of GX-I7 solution or placebo drug for intravaginal injection at the visit 3 (Day0) and 7 (Day28). After completing scheduled tests at the visit 6 (Day 14), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administraion of investigational product | Experimental |
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| Administraion of placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-I7 | Drug | Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate the safety of GX-I7 compared to placebo. | Local and systemic adverse events will be assessed by Department of AIDS (Table for Grading the Severity of Adult and Pediatric Adverse Events, 2004) and Toxicity Grading Scale for Healthy Volunteers Enrolled in Preventive Vaccine Clinical Trials, respectively. Also, vital signs (blood pressure, heart rate, and body temperature), physical examination, laboratory tests, upper abdomen ultrasound, immunogenicity test, and concentration of the investigational drug in blood sample will be assessed throughout the screening and study period. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Humanpapillo Virus (HPV) Persistent Infection of Human Papilloma Virus (HPV) | Perform liquid-based cytology after each injections | at week 0 (Day 0) and week 4 (Day 28) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Kwan Lee, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | 35015 | South Korea | |||
| Yonsei University Health System, Severance Hospital |
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| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
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| Placebo | Drug | This is the placebo of GX-I7 described above. |
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| Seoul |
| 03722 |
| South Korea |
| Hallym University Medical Center-Kangnam | Seoul | 07441 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |